Risperidone is the generic form of Risperdal, a widely prescribed drug produced by Janssen Pharmaceutica Products LP to treat schizophrenia. Janssen is a New Jersey-based unit of Johnson & Johnson.

Mylan said its Risperidone application to the FDA was a so-called first-to-file opportunity. In those cases, pharmaceutical companies that are first-to-file applications and receive FDA approval are entitled to a period of exclusive marketing rights.